GPur- Luminating Oral Cholesterol Kinetics Pilot Study

39 Day Randomized, Open Label, Two Arm Cross Over Study of Clinoptilolite (Gpur) in Healthy Adult Subjects Not Requiring or Receiving Lipid Lowering Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03090542

Acronym

GLOCK-pilot

Enrollment

Registered

2017-03-24

Start date

2017-06-01

Completion date

2018-01-15

Last updated

2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol Absorption

Brief summary

In healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.

Interventions

DIETARY_SUPPLEMENTclinoptilolite

randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults over 18 years of age * Not receiving or requiring lipid lowering therapy * Willingness to give informed consent * Able to keep a dietary log * Willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc)

Exclusion criteria

* Current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins * Current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics * Any oral antibiotic use, currently or within the past 14 days * Diabetes, Type I and Type II * Currently following a restrictive diet * GI motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc) * Prior gastric or bowel resection * Inflammatory bowel disease (Crohns, ulcerative colitis, diverticulitis, celiac sprue, etc) * Co-morbidities with anticipated life expectancy \< 12 months * ESRD on dialysis * Known intolerance to silicium or aluminum compounds * Excess alcohol consumption (\>1 drink per day) * Pregnancy, nursing or not taking/using contraception * Hepatobiliary disorders or renal disease * Plasma total cholesterol \> 240mg/dl or Triglycerides \> 265.5 mg/dl * No plant-sterol enriched food products allowed in diet & supplements * BMI \> 35

Design outcomes

Primary

Measure	Time frame	Description
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days	39 days	Primary Objective

Secondary

Measure	Time frame	Description
Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates	39 days	Secondary Objective
Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements	39 days	Secondary Objective

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026